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Due to children's lower oxygen reserves and higher oxygen consumption, sedation can easily lead to respiratory adverse events such as hypoxemia. It has been reported that the incidence of hypoxemia during pediatric bronchoscopy is high, highlighting that hypoxemia in pediatric painless bronchoscopy is an urgent problem requiring a solution. High-flow nasal cannula (HFNC) oxygen therapy delivers heated and humidified breathing gas with a precisely controllable oxygen concentration, at flow rates exceeding the patient's peak inspiratory flow, directly via unsealed nasal prongs. It is a simple, comfortable, effective, and non-invasive respiratory support method that has been widely adopted in clinical practice. However, the effectiveness of HFNC in pediatric sedation remains unclear. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxemia during sedated bronchoscopy in pediatric patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-flow nasal cannula Group | Experimental |
| |
| Regular Nasal Cannula Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flow nasal cannula | Device | Using High-flow nasal cannula oxygenation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of hypoxemia | 75% ≤ SpO2 < 90% for <60 s | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of sub-clinical respiratory depression | 90% ≤ SpO2 < 95% | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| The incidence of severe hypoxia |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of emergence delirium in pediatric anesthesia | Incidence of emergence delirium in pediatric anesthesia- defined as a Pediatric Anesthesia Emergence Delirium scale score ≥10. Unit of measure: percentage of patients (%). | Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diansan Su | Contact | +86 18616514088 | diansansu@yahoo.com | |
| Mingxia Xu | Contact | +86 13516713435 | xumingxia@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Diansan Su | Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D011014 | Pneumonia |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
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| Regular Nasal Cannula | Device | Using regular nasal cannula for oxygenation |
|
SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s
| Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| Incidence of Other Adverse Events (Excluding Respiratory-Related) | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| Incidence of Other Respiratory-Related Adverse Events | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| Length of stay in the Post-Anesthesia Care Unit (PACU) |
Time from PACU admission until discharge criteria are met (modified Aldrete score ≥9). Unit of measure: minutes. |
| Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
|
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 310000 | China |
|
| Children's Hospital of Chongqing Medical University | Chongqing | China |
|
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |